1. Field of the Invention
The present invention relates to a universal implant fill connector which allows a range of angular motion between the fill tubing and the implant.
2. Description of the Related Art
In various surgical procedures, an implant is placed within a body cavity for subsequent inflation and/or deflation with a fluid.
In plastic and reconstructive surgery, when a breast implant or tissue expander is placed in the dissected pocket, it is typically filled via a fill connector coupled to fill tubing which is attached to a filling material (e.g. saline solution) source. Another example is bariatric surgery where a gastric balloon or gastric band is implanted in or around the stomach for subsequent inflation.
There are currently three basic types of fill connectors used to connect the fluid source to the implant, the choice of which often depends on the implant and the particular surgical approach used. The first is a permanent attachment of the fill tubing to the implant. A common means for this attachment is to make a small opening within the body or shell of the implant and insert the tubing securing it by means of connecting materials such as sleeves, patch assemblies, adhesives or vulcanizing compounds.
The other two common connectors are for temporary attachment of the fill tubing to the implant by means of a valve in the implant which seals after the fill tubing is removed. One of these two temporary attachment means is most commonly used with saline-fill breast implant devices that include a diaphragm valve within the shell. The valve has an opening that requires a rigid male implement to be inserted in the opening thus opening the valve and allowing fluid transfer. This male implement is the fill tip end of the fill connector, which has on the opposite end one or more barbs which accept the flexible (e.g. silicone or vinyl) fill tubing. In use, the fill connector and fill tubing attach to the implant normal to the implant surface.
The other of the two connectors for temporary fill tubing attachment is designed for a leaf valve which consists of parallel sheets of material forming a channel along the surface of the implant into which a cannula or stylet may be inserted. When this valve is engaged, the fill tubing is generally tangent to the implant surface. In breast implant surgery where typically the fill tubing is a temporary attachment, a surgical approach using either the normal or tangential fill tube orientation is selected before the surgical procedure commences. As a result, an ad-hoc determination of which approach to use, which may be necessary because of unexpected developments that arise prior to or during the surgical procedure, is currently impossible. Thus, an accurate analysis,of which surgical approach is best suited to a particular patient""s particular need is necessary before surgery may proceed.
Placement of implants in body cavities is usually performed without visual assistance and in small pockets or within dissected tissue planes. Implant orientation with respect to the tubing position and body opening cannot always be ascertained. Complications can arise because of blocked or kinked tubing or premature detachment of the fill tubing from the implant due to excessive tangential and torsional forces on the inflexible connections. Difficulty in filling, improper fill volume, or inability to complete the filling procedure can all delay surgery, require explant, or require surgery to be aborted.
It is desirable to provide a filling system that can be used for surgical applications calling for either normal or tangential placement of the fill tubing in order to eliminate the requirement for time-consuming analysis before surgery and the potential complications of inflexibly oriented connections during surgery. Thus multiple valves and/or multiple fill tubing geometries may be provided with each implant (i.e. provide both a typical straight fill connector and a 90 degree xe2x80x9cLxe2x80x9d fill connector). This solution, however, still requires multiple product inventories and predetermined patient needs regarding the surgical approach used.
A fill connector could be modified at its barbed, or leakproof fill tubing connection, end to resolve these intra-operative problems and be universally adaptable for any implant or surgical approach. Several design possibilities exist but all entail incorporating a multi-directional connecting means to the implant. Any of these designs would be constructed out of commonly used biocompatible materials, i.e., plastics/elastomers, preferably those compatible with common sterilization processes.
One particular embodiment includes a fill connector with a ball-joint connection having a leak proof fluid pathway therethrough such that the fill tubing may be rotated anywhere from tangential (approximately 0 degrees) to the implant surface up to normal (approximately 90 degrees) to the implant surface.
In a another embodiment, the ball-joint connection could also allow for 360 degree rotation of the fill tubing about an axis approximately normal to the implant surface (i.e., in the plane parallel to the surface of the implant).
An alternative to the ball-joint approach is to use a softer, more flexible material at the barbed end of a typical straight fill connector, while maintaining the standard material (typically polypropylene) at the valve engaging end.
Yet another alternative embodiment is to design the connector with a bellows having accordion-like pleats and appropriately thinner wall sections to allow ease of bending and repeatable multi-directional flexing.